Akorn, Inc.
Form 483 issued May 16, 2018 · Decatur, Illinois
- Inspection
- May 3, 2018
- Investigators
- Michele L. Glendenning· Michele Perry Williams· Sandra A. Hughes
- Observations
- 13
- Pages
- 24
- FEI number
- 1450114
In short: On May 16, 2018, FDA issued a Form 483 with 13 observations to Akorn, Inc. in Decatur, Illinois (FEI 1450114) after an inspection that ran May 3, 2018. The investigators were Michele L. Glendenning, Michele Perry Williams and Sandra A. Hughes. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 314.81 (other postmarketing reports).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 314.81 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological…
- 02
Your firm failed to establish an adequate system for monitoring environmental conditions…
- 03
An annual report did not include a full description of the manufacturing and control changes not…
- 04
Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment…
This inspection in context
Michele L. Glendenning
18 documents · 2018–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Illinois.
The firmAkorn, Inc. history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.81
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Akorn, Inc.?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 314.81 (other postmarketing reports). The opening words of each observation are shown on this page.
Who inspected Akorn, Inc.?
Michele L. Glendenning, Michele Perry Williams and Sandra A. Hughes are named on this Form 483, for the inspection of May 3, 2018. Each investigator has a profile showing what they cite most.
When was Akorn, Inc. inspected by FDA?
The inspection ran May 3, 2018, and the Form 483 is dated May 16, 2018.
How do I get the full Form 483 for Akorn, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.